The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile 6l.
| Device ID | K220350 |
| 510k Number | K220350 |
| Device Name: | KardiaMobile 6L |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AliveCor, Inc. 189 N. Bernardo Ave. Suite 100 Mountain View, CA 94043 |
| Contact | Susan Noriega |
| Correspondent | Prabhu Raghavan MDQR, LLC. 189 N. Bernardo Ave. Suite 100 Mountain View, CA 94043 |
| Product Code | DXH |
| Subsequent Product Code | DPS |
| Subsequent Product Code | QDA |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-05-25 |